Complete Follow-up Research Articles

Efficacy and safety of trimodulin in patients with severe COVID-19: results from a randomised, placebo-controlled, double-blind, multicentre, phase II trial (ESsCOVID)

BackgroundTrimodulin (human polyvalent immunoglobulin [Ig] M ~ 23%, IgA ~ 21%, IgG ~ 56% preparation) has previously been associated with a lower mortality rate in a subpopulation of patients with severe community-acquired pneumonia on invasive mechanical ventilation (IMV) and with clear signs of inflammation. The hypothesis for the ESsCOVID trial was that trimodulin may prevent inflammation-driven progression of severe coronavirus disease 2019 (COVID-19) to critical disease or even death.MethodsAdults with severe COVID-19 were randomised to receive intravenous infusions of trimodulin or placebo for 5 consecutive days in addition to standard of care. The primary efficacy endpoint was a composite of clinical deterioration (Days 6–29) and 28-day all-cause mortality (Days 1–29).ResultsOne-hundred-and-sixty-six patients received trimodulin (n = 84) or placebo (n = 82). Thirty-three patients died, nine during the treatment phase. Overall, 84.9% and 76.5% of patients completed treatment and follow-up, respectively. The primary efficacy endpoint was reported in 33.3% of patients on trimodulin and 34.1% of patients on placebo (P = 0.912). No differences were observed in the proportion of patients recovered on Day 29, days of invasive mechanical ventilation, or intensive care unit-free days. Rates of treatment-emergent adverse events were comparable.A post hoc analysis was conducted in patients with early systemic inflammation by excluding those with high CRP (> 150 mg/L) and/or D-dimer (≥ 3 mg/L) and/or low platelet counts (< 130 × 109/L) at baseline. Forty-seven patients in the trimodulin group and 49 in the placebo group met these criteria. A difference of 15.5 percentage points in clinical deterioration and mortality was observed in favour of trimodulin (95% confidence interval: −4.46, 34.78; P = 0.096).ConclusionAlthough there was no difference in the primary outcome in the overall population, observations in a subgroup of patients with early systemic inflammation suggest that trimodulin may have potential in this setting that warrants further investigation.ESsCOVID was registered prospectively at ClinicalTrials.gov on October 6, 2020.NCT04576728

Development, Progression, and Mortality of Suspected Interstitial Lung Disease in COPDGene.

Some with interstitial lung abnormalities (ILA) have suspected interstitial lung disease (ILD), a subgroup with adverse outcomes. Rates of development and progression of suspected ILD and their effect on mortality are unknown. To determine rates of development and progression of suspected ILD and assess effects of individual ILD and progression criteria on mortality. Participants from COPDGene were included. ILD was defined as ILA and fibrosis and/or FVC <80% predicted. Prevalent ILD was assessed at enrollment, incident ILD and progression at 5-year follow-up. CT progression was assessed visually and FVC decline as relative change. Multivariable Cox regression tested associations between mortality and ILD groups. Of 9,588 participants at enrollment, 267 (2.8%) had prevalent ILD. Those with prevalent ILD had 52% mortality after median 10.6 years, which was higher than ILA (33%; HR=2.0; p<0.001). The subgroup of prevalent ILD with fibrosis only had worse mortality (59%) than ILA (HR=2.2; p<0.001). 97 participants with prevalent ILD completed 5-year follow-up: 32% had stable CT and relative FVC decline <10%, 6% FVC decline ≥10% only, 39% CT progression only, and 22% both CT progression and FVC decline ≥10%. Mortality rates were 32%, 50%, 45%, and 46% respectively; those with CT progression only had worse mortality than ILA (HR=2.6; p=0.005). At 5-year follow-up, incident ILD occurred in 168/4,843 participants without prevalent ILD and had worse mortality than ILA (HR=2.5; p<0.001). Rates of mortality and progression are high among those with suspected ILD in COPDGene; fibrosis and radiologic progression are important predictors of mortality.

Safety of intraoperative autologous plasma incubation of corneal grafts for reducing endothelial cell loss: a pilot study.

Corneal endothelial cell loss contributes to transplant failure. Autologous plasma products (APP) activate salvaging pathways that can prevent oxidative stress perioperatively. This study aimed to evaluate the safety of intraoperative incubation of full-thickness corneal grafts in platelet-rich plasma (aPRP) and plasma rich in growth factors (PRGF-Endoret) in mitigating postoperative corneal endothelial cell loss (ECL). Pilot study including patients undergoing penetrating keratoplasty (PK) for various indications between June 2021 and December 2022. Patients were randomly assigned to receive either aPRP or PRGF-Endoret incubation, while those who declined intervention served as the control group. Demographic and clinical data were collected, including preoperative and postoperative endothelial cell count, intraocular pressure, pachymetry, and adverse reactions. Thirty individuals who underwent PK completed follow-up: eight from the aPRP group, 10 from the PRGF-Endoret group, and 12 from the control group. No adverse events related to APP treatment were recorded. In the first and third postoperative months, the APP group had significantly lower ECL percentages (37% vs. 25%, p = 0.02, and 44% vs. 33%, p = 0.02, respectively); this trend was maintained in the sixth month. When stratified, the PRGF-Endoret group showed significant differences in ECL reduction compared to controls at both time points (p = 0.03 and p = 0.05, respectively). The aPRP group showed a similar statistically significant outcome exclusively on the third postoperative month (p = 0.04). APP tended to reduce corneal edema faster than controls. Hexagonality was significantly better in the APP groups in the first and third months, particularly in the PRGF-Endoret group (p < 0.005). Preoperative incubation with APP is safe and promotes better endothelial cell quality and quantity in the early postoperative period following PK. These findings suggest a potential clinical benefit in enhancing graft outcomes and warrant further investigation.

A giant solitary fibrous tumor of the abdominal pelvic cavity: A case report and literature review.

Solitary fibrous tumor (SFT) is a rare mesenchymal tumor, especially the giant one from the abdominal pelvic cavity. We report on a rare case of a giant SFT of the abdominal pelvic cavity to review the existing literature in detail to improve the diagnosis and treatment of SFT. The patient is a 52-year-old female who presented with 2 weeks of abdominal distension. Abdominal magnetic resonance imaging showed a giant mass (>20 cm) in the abdominal pelvic cavity, considered a mesenchymal tumor. She denies a history of tumor disease. A whole abdomen bulge and a mass of about 18 cm × 10 cm on the right side and middle side were found in the physical examination after admission. Abdominal enhanced computed tomography revealed a giant cystic-solid mass located on the middle and right side of the abdominal pelvic cavity, measuring approximately 20.4 cm × 11.7 cm, with multiple cystic changes and necrosis and compression of adjacent organs and tissues, and marked inhomogeneous enhancement. The patient underwent an open abdominal pelvic cavity giant tumor operation to achieve a radical resection, and did not undergo chemotherapy or radiotherapy. The patient underwent open complete resection of a giant abdominal pelvic tumor with no complications and was diagnosed as SFT according to the pathology, immunohistochemistry showed that the tumor tested positive for CD34(+), STAT-6(+), and Ki-67 (10%). Abdominal computed tomography scans were performed 6 months after resection, and no signs of recurrence or metastasis were found. The clinical symptoms and imaging features of giant abdominal pelvic cavity SFT are not typical. Preoperative diagnosis is difficult and has the potential for malignancy. Based on the results of the current study, there is no standard treatment strategy around the world and the therapeutic effect of radiation therapy and chemotherapy is relatively limited. Thus, complete surgical resection and close clinical follow-up are advocated.

Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema

There are reported benefits from vitrectomy for diabetic macular edema (DME); however, data precede anti-vascular endothelial growth therapy (VEGF) therapy, supporting a need to assess the current role of vitrectomy. To determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&E) anti-VEGF injections for diabetic macular edema (DME). This was a single-masked, multicenter randomized clinical trial at 21 sites in the United Kingdom from June 2018 to January 2021, evaluating single eyes of treatment-naive patients with symptomatic vision loss from DME for less than 1 year. Inclusion criteria were best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score greater than 35 (approximate Snellen equivalent, 20/200 or better) and central subfield thickness (CST) greater than 350 μm after 3 monthly intravitreal injections of ranibizumab or aflibercept. Data analysis was performed in July 2023. Patients were randomized 1:1 into vitrectomy plus standard care or standard care alone and further stratified into groups with vs without vitreomacular interface abnormality. Both groups received a T&E anti-VEGF injection regimen with aflibercept, 2 mg, or ranibizumab, 0.5 mg. The vitrectomy group additionally underwent pars plana vitrectomy with epiretinal membrane or ILM peel within 1 month of randomization. Rate of recruitment and distance BCVA. Secondary outcome measures were CST, change in BCVA and CST, number of injections, rate of completed follow-up, and withdrawal rate. Over 32 months, 47 of a planned 100 patients were enrolled; 42 (89%; mean [SD] age, 63 [11] years; 26 [62%] male) completed 12-month follow-up visits. Baseline characteristics appeared comparable between the control (n = 23; mean [SD] age, 66 [10] years) and vitrectomy (n = 24; mean [SD] age, 62 [12] years) groups. No difference in 12-month BCVA was noted between groups, with a 12-month median (IQR) BCVA letter score of 73 (65-77) letters (Snellen equivalent, 20/40) in the control group vs 77 (67-81) letters (Snellen equivalent, 20/32) in the vitrectomy group (difference, 4 letters; 95% CI, -8 to 2; P = .24). There was no difference in BCVA change from baseline (median [IQR], -1 [-3 to 2] letters for the control group vs -2 [-8 to 2] letters for the vitrectomy group; difference, 1 letter; 95% CI, -5 to 7; P = .85). No difference was found in CST changes (median [IQR], -94 [-122 to 9] μm for the control group vs -32 [-48 to 25] μm for the vitrectomy group; difference, 62 μm; 95% CI, -110 to 11; P = .11). Enrollment goals could not be attained. However, with 47 participants, evidence did not support a clinical benefit of vitrectomy plus ILM peeling as an adjunct to a T&E regimen of anti-VEGF therapy for DME. isrctn.org Identifier: ISRCTN59902040.

User Experiences With a Moderated Facebook Group to Promote Vaccination.

To examine user experiences in a moderated Facebook group intervention aimed at Coronavirus disease 2019 (COVID-19) vaccine promotion. Facebook group members were given 2-3 vaccination posts/day for 28days (fourweeks). Posts were aimed at educating about COVID-19 vaccination, soliciting concerns around COVID-19 vaccination, and engaging members. Participants were surveyed about their experience at four weeks. Moderated Facebook group. Unvaccinated individuals who were randomized to the intervention group and completed fourweek follow-up (N = 216, 82.1%). After fourweeks, participants rated their experience in the Facebook group (eg, program satisfaction) and provided open-text responses about their satisfaction with the group. Free-text responses were dual coded and emergent themes were examined. On average, participants were 37.0 years old (SD = 10.3), majority female (70.9%), and white (79.7%). The majority of participants were satisfied with the group (76.7%), agreed that other people were friendly (M = 5.58/7), and felt safe discussing health information (M = 3.96/5). Open-text responses revealed that participants liked the program because they thought the information was useful (27.7%), other members were friendly (16.1%), and the group was a safe place (13.8%). While many responded that there was nothing they did not like about the program (37.6%), nearly one-third (31.9%) reported disliking the program because it appeared to be too much in favor of vaccination and because other members came across as rude (7.1%). Those with conservative political views were less likely to be satisfied with the group (P = .04). Facebook groups represent an acceptable way to engage participants to improve vaccination against COVID-19. Some aspects of the Facebook group could be improved for future iterations.

Usefulness of mindfulness for the management of anxiety, stress, and quality of life in infertile women. A clinical exploratory study.

Infertility increases stress and affects life quality. Mindfulness reduces stress and improves life quality, but its role in infertility remains unclear. To evaluate the effect of mindfulness on stress and quality of life of women with infertility. An exploratory clinical study was conducted in women under infertility treatment, together with an 8-week mindfulness intervention (MND) or only infertility treatment (CTRL). Anxiety and quality of life were assessed at baseline and at the end of intervention with IDARE and FertiQoL questionnaires respectively, as well as salivary alpha-amylase and cortisol concentrations. Non-parametric statistics was used for analysis using an alpha value of 0.10. 14 MND and 15 CTRL completed follow-up. At baseline, CTRL patients exhibited better quality of life than MND; anxiety scores correlated negatively with quality of life. At the end of intervention, cortisol concentrations (p = 0.097), and the increments of amylase (p = 0.039), were higher in CTRL than in MND. Increases in quality of life were associated with basal anxiety score (p = 0.002), improvements in tolerability (p < 0.001), and mindfulness intervention (p = 0.014). Our results suggest that mindfulness reduces stress and improves quality of life in women under infertility treatment.

Validity of a single-item indicator of treatment side effect bother in patients with head and neck cancer.

Patients with head/neck squamous cell carcinomas (HNSCC) experience significant tumor- and treatment-related side effects. No efficient summary measure capturing the totality of side effect burdencurrently exists. We examined associations between a single patient-reported outcome (PRO) item evaluating side effect bother (FACT GP5, "I am bothered by side effects of treatment") with overall side effects in HNSCC. We performed a retrospective secondary analysis of development of the Functional Assessment of Cancer Therapy (FACT) Head/Neck Symptom Index (FHNSI-10), which included completing FACT-HN (including Head/Neck Cancer Subscale (HNCS) and Trial Outcome Index (TOI)) and the pain intensity numeric rating scale (NRS). We calculated Spearman's correlations between GP5 and these measures of patient-reported global health, head/neck side effects, and pain intensity NRS. A correlation of > 0.4 was considered sufficient evidence of association. Ninety-seven patients completed baseline and 85 completed 3-month follow-up surveys. GP5 was highly correlated with FACT-HN total score (baseline r = 0.66, 3months r = 0.67) and FHNSI-10 (baseline r = 0.63, 3months r = 0.65). GP5 correlated with multiple FACT-HN subscales including FACT-G, physical well-being, functional well-being, HNCS, and TOI (range baseline r = 0.53-0.77, range 3months r = 0.49-0.77). Worsening GP5 score was associated with worsening overall HNCS (p = 0.002), worsening FHNSI-10 score (p < 0.001), and worsening mean pain intensity (p < 0.001). GP5 exhibited validity within HNSCC, exhibiting substantial correlations with a number of HNSCC-related PRO measures including FACT-HN and FHNSI-10. Worsening GP5 was associated with worsening HNCS, FHNSI summary score, and pain intensity. GP5 has promise as a summary indicator of symptom and side effect bother in HNSCC.

AM/PM dosing of LAMA for COPD: a randomized controlled trial protocol using digital recruitment and registries.

Long-acting muscarinic antagonists (LAMAs) reduce the risk of acute exacerbations of chronic obstructive pulmonary disease (AECOPD), usually taken once daily in the morning. However, the circadian activity of autonomic regulation suggests that the highest need for anticholinergic therapy may be in the late night/early morning. This is supported by evidence that AECOPD most often begins in the morning. Furthermore, the trough spirometry effect of LAMA is lower than the peak effect, which further argues that evening dosing may be more optimal than morning dosing. This trial aims to determine whether evening administration of LAMA reduces hospitalization-requiring AECOPD or death from all causes within 1 year as compared to morning administration of the same LAMA. Randomized controlled open-label trial. Persons aged 30 years or older with a once-daily LAMA prescription and a confirmed COPD diagnosis were recruited. Participants were randomized in a 1:1 ratio to either morning or evening LAMA administration. Complete follow-up for the primary outcome, hospitalization-requiring AECOPD, or death from all causes within 1 year was captured from the Danish National Health Register, as were patient-reported outcome assessments at 6 and 12 months. A total of 10,013 participants were randomized, and the recruitment process started on 9 March 2023. Secondary outcomes include (i) moderate COPD exacerbations; (ii) all-cause hospitalization; (iii) ICU admission; (iv) need for non-invasive ventilation; and (v) all-cause mortality, among others. All outcomes will be evaluated 12 months after recruitment.Clinical trial registration:ClinicalTrials.gov, NCT05563675.

Medial-pivot design does not provide superior clinical results compared to posterior-stabilized total knee arthroplasty despite kinematic differences during step-up and lunge activities: A prospective randomized controlled trial under medial tight soft tissue balance.

This study aimed to compare in vivo kinematics during weight-bearing daily activities and determine the relationship with clinical outcomes in patients undergoing total knee arthroplasty (TKA) with a medial-pivot (MP, Evolution™) versus a posterior-stabilized (PS, Persona®) design under constant conditions of intraoperative soft tissue balance. Forty patients undergoing MP or PS-TKA under similar conditions of soft tissue balance were enrolled in this prospective randomized controlled trial. Outcome measures included clinical knee society scores (KSS) and knee injury and osteoarthritis outcome scores (KOOS). A kinematic assessment was conducted while the participants performed lunge and step-up activities under fluoroscopic guidance. Eighteen patients in each arm completed 1-year follow-up and were included in the analysis. All patients experienced pain relief and satisfactory knee function postoperatively. In kinematics, in the MP arm, the medial femoral condyle remained consistent, whereas the lateral femoral condyle gradually shifted posteriorly with increasing knee flexion. Conversely, in the PS arm, paradoxical anterior movement of the medial femoral condyle accompanied the lateral pivot motion. During lunge and step-up activities, a medial-pivot motion was observed in 83% and 72% of knees in the MP arm, respectively, compared with 22% and 11% in the PS arm. Despite these differences in kinematics, there were no statistically significant differences in the KSS and KOOS between the two groups. Under weight-bearing conditions during flexion, knees that underwent Evolution™ MP-TKA did not show superior clinical results compared to Persona® PS-TKA, despite exhibiting in vivo kinematics closely resembling the normal in vivo pattern. Therapeutic studies-Level I.

Standardizing a transitions of care pharmacist workflow for tobacco cessation efforts

BackgroundSmoking is the leading cause of preventable disease, disability, and death. Pharmacists can aid in smoking cessation through pharmacotherapy recommendations, patient counseling, and follow-up. ObjectiveDescribe a standardized transitions of care (TOC) pharmacist workflow for patients' tobacco cessation efforts at hospital discharge and to secondarily evaluate patient participation, impact on cessation outcomes, and pharmacist effort to provide the service. Practice descriptionTOC pharmacists provide medication optimization and education to patients admitted to and discharged from Norton Healthcare hospitals. Medication optimization for tobacco cessation occurs through a provider recommendation or by utilizing the Kentucky Board of Pharmacy–authorized protocol. Practice innovationA standardized workflow was created for TOC pharmacists to identify patients who use tobacco, assess patients’ current tobacco use and willingness to quit, select appropriate pharmacotherapy, document, and follow up after discharge. Evaluation methodsA retrospective descriptive study was performed for adult patients assessed by TOC pharmacists for tobacco cessation between November 2021 and April 2022, with follow-up visits completed through December 2022. ResultsThe pharmacists assessed 357 patients and 252 (70.6%) stated they were interested in tobacco cessation. Of those interested, 117 patients (46.4%) indicated they were interested in receiving follow-up from TOC pharmacists and refills from a Norton pharmacy. Of the 117 patients interested in follow-up, 73 patients (62.4%) completed at least 1 follow-up visit with the TOC pharmacist. At the last completed follow-up visit, 26 patients (35.6%) reported complete tobacco cessation. Of the 47 patients who did not have complete cessation, they reported using 39% less tobacco on average compared with their initial assessment at hospital discharge. The mean time spent by TOC pharmacists using this workflow was 13.5 minutes per follow-up visit. ConclusionsThis project formalized a standardized and sustainable TOC pharmacist workflow that demonstrated a positive impact on tobacco cessation efforts for participating patients.

Choroidal Vascularity and Axial Length Elongation in Highly Myopic Children: A 2-Year Longitudinal Investigation.

To examine the influence of subfoveal choroidal thickness (SFCT) and choroidal vascularity index (CVI) on axial length (AL) elongation over a 2-year period in highly myopic children. In this is prospective, longitudinal, observational study, 163 participants (74%), who were 8 to 18years of age with bilateral high myopia (sphere ≤ -6.0 D) and without pathologic myopia, completed follow-up visits over 2years. All participants underwent baseline and follow-up ocular examinations, including swept-source optical coherence tomography (SS-OCT) and AL measurements. SFCT and CVI were derived from SS-OCT scans using a deep-learning-based program for choroidal structure assessment. The mean age of the participants at baseline was 15.0years (±2.3), with males constituting 47% of the cohort. An inverse relationship was observed between AL elongation and increases in baseline age, baseline SFCT, and CVI, as well as a decrease in baseline AL. Adjusting for other factors, every 10-µm increase in SFCT and each 1% increase in CVI were associated with decreases in AL elongation of 0.007mm (95% confidence interval [CI], -0.013 to -0.002; P = 0.011) and 0.010mm (95% CI, -0.019 to 0.000; P = 0.050), respectively. The incorporation of SFCT or CVI into predictive models improved discrimination over models using only age, gender, and baseline AL (both P < 0.05, likelihood ratio test). Our findings suggest a possible association between a thinner choroid and increased AL elongation over 2 years in children with high myopia, after adjusting for potential baseline risk factors such as age, gender, and initial AL.

A Randomized Controlled Comparison of Guardian-Perceived Cosmetic Outcome of Simple Lacerations Repaired With Either Dermabond, Steri-Strips, or Absorbable Sutures.

The aim of this study was to compare the guardian-perceived 3-month cosmetic outcome for pediatric lacerations repaired with absorbable sutures, Dermabond, or Steri-Strips. Secondarily, pain and satisfaction with the procedure from both guardian and provider perspectives were compared. In this randomized controlled trial, we enrolled a convenience sample of children aged 0 to <18 years who presented with simple linear lacerations (≤5 cm in length, ≤0.5 cm in width, and <12 hours old) to a pediatric emergency department. Children were randomized to receive laceration repair with absorbable sutures, Dermabond, or Steri-Strips. Topical L.E.T. solution (lidocaine, epinephrine, tetracaine) was applied to wounds which were then closed by the primary team. Guardians and providers completed questionnaires regarding perceived pain and satisfaction with the procedure. Guardians were contacted 3 months after the repair and asked to email a picture of the scar with their perception of cosmesis rated on a visual analog scale from 0 to 100. Fifty-five patients were enrolled, of whom 30 completed 3-month follow-up (12 suture, 7 Dermabond, 11 Steri-strips). There was no statistical evidence of an association between scar appearance and closure method based on medians and interquartile ranges for cosmetic ratings of scar: suture median 70.5 (IQR 59.8-76.8), Dermabond median 85 (IQR 73-90), Steri-strips median 67 (IQR 55-78) (P = 0.254). Guardian satisfaction with length of stay, guardian and physician satisfaction with the procedure, and guardian and physician-perceived pain also showed no differences. No differences were observed in guardian-perceived cosmesis of simple lacerations repaired with sutures, Dermabond, or Steri-Strips when evaluated 3 months after intervention. In addition, there were no differences in guardian or physician-perceived pain or satisfaction with the closure methods. The results of this study suggest that all 3 closure methods appear to be clinically equivalent, which is largely consistent with other evidence. Further study should be expanded to a larger demographic.

Utilizing Leadless Pacemakers in Extremely Elderly Patients With a Conventional Pacemaker System: A Two-Year Follow-Up Case Series Without Generator Extraction in High-Risk Scenarios.

Background and objectives Leadless pacemakers, known for their safer clinical profile, offer significant advantages for elderly patients at a higher risk of complications associated with transvenous pacemaker procedures, particularly those susceptible to high-risk bleeding and infections related to cardiac implantable electronic device interventions. This study explores an alternative use of leadless pacemakers without removing existing transvenous systems, deviating from conventional generator replacement and lead re-interventions. Methods This study was conducted with full approval from the Institutional Review Board, Medical Ethical Committee, Centro Hospitalar Conde São Januário, Macau. Between January 2018 and December 2021, we conducted a retrospective case series involving extremely elderly individuals (aged 85 years or older) at a high risk of complications, necessitating either generator replacement or lead re-implantation. The study considered implanting a leadless pacemaker (Micra; Medtronic,Minneapolis, MN, USA) without removing the transvenous generator. For the primary endpoints, we evaluated procedure-related complications and clinical outcomes during hospitalization. Secondary endpoints included the stability of parameters and any unexpected interference or interactions between the two systems during the two-year follow-up. Results Eleven patients (aged 86-101) were enrolled, most receiving antiplatelet or anticoagulation therapy. Leadless pacemaker implantation proceeded without major complications or adverse clinical outcomes during hospitalization. Regular follow-up was conducted every three to six months for adjusting pacemaker parameters and interrogating each patient. Over two years, three patients died from non-cardiac causes: two from infection and one from spontaneous intracranial hemorrhage, while eight completed regular follow-ups. We didn't detect any episodes of ventricular arrhythmias or intracardiac capture from the transvenous pacemaker system. We observed the stability in both the longevity and the voltage of the conventional generator battery, maintaining similar parameters without significant depletion (mean voltage decline: -0.07V/year). Parameters of the leadless pacemaker remained consistently normal without interference with existing pacing systems. Conclusion Implanting leadless pacemakers without removing transvenous pacemaker generators appears safe and effective for extremely elderly patients who are at high risk of complications. Comprehensive two-year follow-up supports the safety and viability of this approach. Opting for this approach instead of conventional generator replacement, with or without additional lead implantation, may be reasonable in this population. However, further research within this patient cohort, such as exploring long-term outcomes beyond two years or comparing clinical outcomes with conventional strategies, may be necessary.

Beyond childhood: exploring the state of transitional care in pediatric pilocytic astrocytoma.

Pediatric pilocytic astrocytoma (PPA) requires prolonged follow-up after initial resection. The landscape of transitional care for PPA patients is not well characterized. The authors sought to examine the clinical course and transition to adult care for these patients to better characterize opportunities for improvement in long-term care. Pediatric patients (younger than 18 years at diagnosis) who underwent biopsy or resection for PPA between May 2000 and November 2022 at the authors' large academic center were retrospectively reviewed. Patient demographics, tumor characteristics, recurrence, adjuvant therapies, and follow-up data were extracted from the electronic medical record via chart review. Charts of patients who were 18 years or older as of January 1, 2024, were reviewed for adult follow-up notes. The authors identified 315 patients who underwent biopsy or resection for PPA between May 2000 and November 2022. The most common tumor location was posterior fossa (59.7%), and gross-total resection (GTR) was achieved in 187 patients (59.4%). In patients with GTR, progression/recurrence occurred less frequently (8.6% vs 41.4%, p < 0.01) compared to patients with non-GTR. Among 177 patients found to be age-eligible for transition to adult care, the authors found that 31 (17.5%) successfully transitioned. The average age at transition from pediatric to adult care was 21.7 years, and the average age at last known adult follow-up was 25.0 years. The authors found that patients who transitioned to adult care were followed longer (12.5 vs 7.0 years, p < 0.01) and were diagnosed at an older age (12.1 vs 9.6 years, p < 0.01) than their untransitioned counterparts. The authors found that there was a low rate of successful transition from pediatric to adult care for PPA; 17.5% of age-eligible patients are now cared for by adult providers, whereas an additional 18.6% completed appropriate follow-up during childhood and did not require transition to adult care. These findings underscore opportunities for improvement in the pediatric-to-adult transition process for patients with PPA, particularly for those with non-GTR who were not followed for at least 10 years, during which the risk of disease progression is thought to be highest.

Digital Storytelling Intervention for Hemoglobin A1c Control Among Hispanic Adults With Type 2 Diabetes

Hispanic adults with type 2 diabetes (T2D) are more likely to develop complications and die from the disease than the US general population. Digital storytelling interventions are narrative-based videos elicited through a community-based participatory research approach to surface the authentic voices of participants overcoming obstacles to health-promoting behaviors that perpetuate health inequities; research on the effect of digital storytelling on T2D outcomes among Hispanic adults is lacking. To assess the impact of a digital storytelling intervention on glycemic control and its acceptability among Hispanic patients with poorly controlled T2D. This was a multicenter, randomized clinical trial conducted within 2 primary care networks in Minnesota and Arizona among Hispanic adults with poorly controlled T2D (hemoglobin A1c level ≥8%). Enrollment and follow-up were conducted between February 14, 2019, and November 1, 2023. The intervention group viewed a 12-minute digital storytelling video. The video included 4 Spanish-language stories that reinforced 4 diabetes self-management behavioral goals (healthful diet for diabetes, physical activity, medication adherence, and glucose self-monitoring). The control group received printed, culturally tailored T2D education materials. The primary outcome was the mean change from baseline to 3 months for hemoglobin A1c levels, adjusting for baseline hemoglobin A1c, age, gender, education, and income. Acceptability and narrative quality of the intervention were assessed through questionnaires. There were 451 study participants, with 227 (mean [SD] age, 54.3 [9.3] years; 158 [69.3%] women) randomized to the intervention group and 224 (mean [SD] age, 54.5 [9.1] years; 156 [69.3%] women) to the control group. Of these, 390 completed 3-month follow-up of the primary outcome (86% retention). There was a small improvement in the mean (SD) hemoglobin A1c level in the intervention group compared with the control group in the adjusted model (9.1% [1.7] to 8.4% [1.6] vs 9.4% [1.8] to 8.8% [2.0]; P = .04] but not in the unadjusted model. Acceptability and narrative quality of the intervention were high. In this randomized clinical trial, a digital storytelling intervention developed with and for Hispanic adults with T2D was highly acceptable and feasibly implemented within primary care settings and resulted in a modest improvement of glycemic control. This was a highly scalable intervention that may be integrated into clinical practice as part of a longitudinal diabetes self-management program for Hispanic adults. ClinicalTrials.gov Identifier: NCT03766438.

Specific metabolic impairments indicate loss of sustained liver improvements in metabolic dysfunction-associated steatotic liver disease treatment.

High liver fat content (LFC) induces increased risks of both hepatic and extrahepatic progression in metabolic dysfunction-associated steatotic liver disease (MASLD), while maintaining a significant decline in magnetic resonance imaging-based proton density fat fraction (MRI-PDFF) (≥30% decline relative to baseline) without worsening fibrosis results in improved histological severity and prognosis. However, the factors associated with the loss of sustained responses to treatment remain unclear, and we aim to identify them. Consecutive treatment-naïve MASLD patients between January 2015 and February 2022, with follow-up until April 2023, were included in this prospective cohort study. LFC quantified by MRI-PDFF and liver stiffness measurements (LSM) determined by two-dimensional shear wave elastography (2D-SWE) were evaluated at weeks 0, 24 and 48. MRI-PDFF response was defined as a ≥30% relative decline in PDFF values, and LSM response was defined as a ≥1 stage decline from baseline. A total of 602 MASLD patients were enrolled. Of the 303 patients with a 24-week MRI-PDFF response and complete follow-up of 48 weeks, the rate of loss of MRI-PDFF response was 29.4%, and multivariable logistic regression analyses showed that 24-week insulin resistance (IR), still regular exercise and caloric restriction after 24 weeks, and the relative decline in LFC were risk factors for loss of MRI-PDFF response. Loss of LSM response at 48 weeks occurred in 15.9% of patients, and multivariable analysis confirmed 24-week serum total bile acid (TBA) levels and the relative decline in TBA from baseline as independent predictors. No significant association was found at 48 weeks between loss of MRI-PDFF response and loss of LSM response. MASLD patients with IR and high TBA levels are at higher risks of subsequent diminished sustained improvements of steatosis and fibrosis, respectively.

Otitis media sequelae and hearing in adolescence after administration of an 11-valent conjugate pneumococcal vaccine in infancy: a prospective cohort study with long-term follow-up of the ARIVAC trial

Pneumococcal conjugate vaccines (PCVs) have been shown in randomised controlled trials and epidemiological studies to prevent acute otitis media caused by vaccine serotype pneumococci, although their role in preventing complications of acute otitis media is less clear. We hypothesised that the 11-valent PCV would reduce the long-term sequelae of acute otitis media, including moderate-to-severe ear disease and hearing loss. This prospective cohort study, referred to as 11PCV study, included follow-up after 16-20 years of children previously enrolled in 2000-04, at age 6 weeks to 6 months, in the randomised, placebo-controlled, ARIVAC trial of 11-valent PCV for the prevention of radiographical pneumonia. The ARIVAC trial and this 11PCV study were conducted at six study centres in Bohol, Philippines. Ear disease was classified using video-otoscopy review and observations derived from the ear exam. The final classification of the worst ear disease was mild (ie, acute otitis media, otitis media with effusion, healed perforation, or tympanosclerosis), moderate (ie, dry perforation or adhesive otitis media), or severe (chronic suppurative otitis media). Hearing loss was assessed following a standard schema and classified according to the worst ear as mild (>15 to 30 dB puretone average) or moderate-to-profound (>30 dB pure tone average). We calculated the relative and absolute risk reduction in the primary outcome of moderate-to-severe ear disease and the secondary outcomes of mild or moderate-to-profound hearing loss in adolescents who previously received the 11-valent PCV compared with those who received placebo during infancy in ARIVAC. Of the 15 593 children assessed for eligibility in ARIVAC, 12 194 were randomly assigned and 8926 were alive and could be located for enrolment in this 11PCV study between Sept 19, 2016, and Dec 13, 2019. 8321 (4188 in the vaccine group and 4133 in the placebo group) completed follow-up of the 11PCV study by March 30, 2020, and had sufficient data to classify ear disease and be included in the primary outcome analysis. The primary outcome of the absolute risk reduction in moderate-to-severe ear disease in the vaccine group (310 [7·4%] of 4188) versus those in the placebo group (356 [8·6%] of 4133) was 1·2% (95% CI 0·0-2·4; p=0·046) and the relative risk reduction was 14·1% (0·0 to 26·0). There were no differences in secondary outcomes of mild hearing loss or moderate-to-profound hearing loss between the vaccine and placebo groups. The absolute risk reduction for moderate-to-severe ear disease in adolescence of 1·2% (12 per 1000 children) was almost three times higher than the 0·45% reduction (4·5 per 1000 children) in radiographical pneumonia in the first 2 years of life shown in ARIVAC. Administration of 11-valent PCV in infancy was associated with absolute and relative risk reductions in the sequelae of acute otitis media 16-20 years after the original ARIVAC trial. Bill & Melinda Gates Foundation.

Cognitive predictors of response to interpersonal and social rhythm therapy in mood disorders.

There has been increasing interest in examining the potential moderating effects that cognitive functioning has on treatment outcome in bipolar disorder (BD) and major depressive disorder (MDD). Therefore, the aim of this exploratory study was to examine the relationship between baseline cognitive function and treatment outcome in individuals with mood disorders who completed 12 months of interpersonal and social rhythm therapy (IPSRT), and were randomised to receive adjunctive cognitive remediation (CR) or no additional intervention. Fifty-eight patients with mood disorders (BD, n = 36, MDD, n = 22), who were randomised to IPSRT-CR or IPSRT, underwent cognitive testing at baseline and completed follow-up mood measures after 12 months. General linear modelling was used to examine the relationship between baseline cognitive function (both objective and subjective) and change in mood symptom burden, and functioning, from baseline to treatment-end. Poorer baseline attention/executive function was associated with less change in mood symptom burden, particularly depressive symptoms, at treatment-end. Additionally, slower psychomotor speed at baseline was associated with less improvement in mania symptom burden. Subjective cognitive function at baseline was not related to change in mood symptom burden at treatment-end, and neither objective nor subjective cognitive function was associated with functional outcome. Due to the exploratory nature of the study, there was no correction for multiple comparisons. Aspects of objective cognitive function were associated with treatment outcomes following psychotherapy. Further large-scale research is required to examine the role that cognitive function may have in determining various aspects of mood disorder recovery.

Comparison of the efficacy of LARS ligament and autogenous hamstring tendon plus high-strength suture in posterior cruciate ligament reconstruction

To compare the clinical efficacy of ligament advanced reinforcement system (LARS) and autogenous hamstring tendon plus high-strength suture in arthroscopic reconstruction of posterior cruciate ligament(PCL). A total of 96 patients with simple PCL injury treated with arthroscopic posterior cruciate ligament reconstructive surgery admitted to our hospital between August 2019 and December 2021 were selected for complete follow-up. There were 78 males and 18 females, 40 cases of left leg and 56 cases of right leg, the aged from 20 to 56 years old with an average of (32.50±8.68 ) years old. The transplants were divided into two groups:LARS group (52 cases) and autogenous hamstring tendon plus high-strength suture group (44 cases). In the LARS group, there were 42 males and 10 females;with an average age of (31.84±8.62) years old;body mass index (BMI) was (24.73±2.29) kg﹒m-2;7 mm LARS was used to reconstruct PCL. In the autologous tendon group, there were 36 males and 8 females, with an average age of (33.06±8.99) years old, BMI was (23.52±2.16) kg·m-2, and the PCL was reconstructed with four strands of hamstring tendons and three pieces of Ethibond suture. All patients underwent functional rehabilitation guided exercise and were followed up regularly after surgery to objectively evaluate the stability of the knee joint by KT-1000 measurement of knee relaxation, and subjective evaluation of knee function by Lysholm score, Tegner score, and International Knee Documentation Council (IKDC) score. Data from preoperative, 3, 6, and 12 month follow-up were collected and analyzed by SPSS software to compare postoperative recovery and ligament relaxation between the two groups of patients. Ninety-six patients were followed up for 12 months. KT-1000 measurement of knee joint in autogenous tendon group and LARS group before operation [(10.73±1.46) points vs (10.55±1.53) points], 6 months after operation[(3.02±0.75) points vs (2.35±0.60) points], 12 months after operation[(3.77±1.76) points vs (2.44±0.60) points]. There was significant difference between the two groups at 6 and 12 months after operation (P<0.05), but there was no significant difference between the two groups at 3 months after operation (P>0.05). In the autogenous tendon group and LARS group, before operation and 12 months after operation, total Lysholm score [(40.6±16.8), (91.25±6.35) points vs (51.92±18.52), (92.35±5.30) points], Tegner score[(1.8±0.7), (5.8±0.6) points vs(1.7±0.8)、(5.7±0.7) points] and total IKDC score[(54.50±6.33), (83.90±3.93) points vs (54.40±4.24), (83.62±3.64) points], the differences were statistically significant (P<0.05), indicating that the knee function of the two groups was improved after surgery. At 3 and 6 months after operation in the autogenous tendon group and LARS group, the total Lysholm score[(65.86±11.54), (74.60±6.46) points vs (73.46±6.42), (86.73±4.62) points], Tegner score[(2.5±0.6), (3.5±0.5) points vs (4.3±0.7), (5.0±1.4) points], the total scores of IKDC [(55.78±2.68), (70.62±4.74) points vs (65.31±4.60), (79.71±2.93) points]. The difference between two groups was statistically significant (P<0.05). The results showed that the function of the knee joint in the LARS group was better than that the autologous tendon group. However, at 12 months after the operation, there was no significant difference in the score of knee joint function between the two groups (P>0.05). The results showed that the stability of LARS group was better than that of autologous tendon group. Both the autogenous hamstring tendon plus high-strength suture and LARS reconstruction can significantly improve the knee function and stability, with satisfactory postoperative results. Howervr the LARS provides superior postoperative stability.